# K250221: StrokeSENS ASPECTS Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Jul 1, 2025 after 158 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170022 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221564: Brainomix 360 e-ASPECTS, Brainomix Limited (2023) Summary page 6.

## Indications for use
StrokeSENS ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and uses an Atlas to segment and analyze ASPECTS Regions. StrokeSENS ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. StrokeSENS ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. StrokeSENS ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 12 hours from time last known well). StrokeSENS ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. StrokeSENS ASPECTS presents the original and annotated images for concurrent reads. StrokeSENS ASPECTS additionally provides a visualization of the voxels contributing to the automated ASPECTS score. Limitations: 1. StrokeSENS ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. StrokeSENS ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECTS scoring. 3. Use of StrokeSENS ASPECTS in clinical settings other than brain ischemia within 12 hours from time last known well, caused by known ICA or MCA occlusions, has not been tested. 4. StrokeSENS ASPECTS has only been validated and is intended to be used in patient populations aged over 21. Contraindications: * StrokeSENS ASPECTS is contraindicated for use on brain scans displaying neurological pathologies other than acute ischemic stroke, such as tumors or abscesses, hemorrhagic transformation, and hematoma. Cautions: * Patient Motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.

Source page: https://510kreport.com/device/K250221
Methodology: https://510kreport.com/methodology